The Randomized, Double-blind, Multi-center, Based On Standard Therapy, Placebo-controlled Study Of The Efficacy And Safety Of Recombinant Oral Tolvaptan In Patients With Chronic Systolic Heart Failure

Background: Hyponatremia constitutes a common serum electrolyte abnormality inthe hospitalized patients. Hyponatremia is reported to be an independent predictor ofcomplications and death in patients with heart disease. The high volume of hyponatremiacaused by Heart failure should actively diuresis.However，diuresis can lead to a further lossof sodium salt，Common diuretics can not bring comprehensive treatment. The secretionexcessive of AVP is the causes of hyponatremia，So as to reduce the concentration of theAVP or antagonism it on kidney function become the research direction of treatment withhyponatremia. In recent years, there are many literatures that vasopressin V2receptorantagonist have an impact on kidney V2receptor antagonist AVP.(Relieve the fluidretention, Reduce the edema,) So, Treatment of hyponatremia.the quality of life, reducingmortality. Someone put the antagonist called "water pills". it is an important idealtherapeutic drugs to Tolvaptan which treat with Heart failure and other diseases,, it has favorable perspective of clinical application.Objective: To investigate the efficacy and safety of recombinant oral Tolvaptan inhyponatremia patients with heart failure.Method: After strict selection for mild chronic hyponatremia patients with heartfailure from November.2011to November.2012,76cases were enrolled, and all thepatients received a randomized, double-blind, multi-center, based on standard therapy,placebo-controlled study. After7days administration of the drug, all the patients wererespectively followed at the1day to7day，were given at of the Serum sodium，recordedthe signs and symptoms and fluid balance of heart failure which happened in7day medicinebefore and after medication. and given a comprehensive assessment of the effectiveness andsafety. Six patients have serious adverse events,and11patients had adverse reactions.Result: Tolvaptan showed a better favorable clinical therapeutic effect with respect tothe main and secondary observed index rather than placebo，which could improve Sodiumlevels of the subjects，that reflected by the enhanced Serum sodium. It is calculate thevariation of1to7day serum sodium value compared with the baseline serum sodium valuein Tolvaptan：6.314.67；It is calculate the variation of1to7day serum sodium valuecompared with the baseline serum sodium value in placebo：3.573.51. Statistic analysisshowed that the two group discrepancy of the two groups had a significant difference(p<0.0001). About observation of safety, Six patients have serious adverse events.Conclution: With Tolvaptan to treat mild chronic hyponatremia patients caused bycongestive heart failure, can significantly improve the patient’s heart function, increas ingthe patient’s serum sodium value, reducing water retention, the adverse reaction is less, thetreatment of congestive heart failure is effective and safe.